510(k) · Cleared
ClearedStryker SonicPin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma GmbH · HTY Pin, Fixation, Smooth
Cleared on Jun 20, 2017 as substantially equivalent to K143063 (Stryker Trauma GmbH, 2015) after a 127-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Jun 20, 2017
- Review
- 127 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K050749 (2005). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK050749 Arthrex Tak FamilyArthrex, Inc. · 2005
- 2 generations backK063479 Arthrex PushlockArthrex, Inc. · 2006
- 1 generation backK143063 Stryker SonicPin System, Stryker SonicAnchor SystemStryker Trauma GmbH · 2015
- This deviceK170418 Stryker SonicPin SystemStryker Trauma GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050749 | Arthrex Tak Family | Arthrex, Inc. | 2005 | — |
| −2 | K063479 | Arthrex Pushlock | Arthrex, Inc. | 2006 | — |
| −1 | K143063 | Stryker SonicPin System, Stryker SonicAnchor System | Stryker Trauma GmbH | 2015 | — |
| 0 (this device) | K170418 | Stryker SonicPin System | Stryker Trauma GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HTY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143063 | Stryker SonicPin System, Stryker SonicAnchor SystemSummary page 4…Fax: +49 4348 702 8637 Date Prepared: June 6, 2017 Primary Predicate: Stryker SonicPin System (K143063) Description This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the modified bior… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170418: Stryker SonicPin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170418
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026